The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

The Aware™ Pad is intended to be used as an aid for performing breast self
Aware Breast Self-Exam Pad - 1207

A device intended to be used to perform a tactile self-breast examination for abnormalities, typically unfamiliar changes/lumps in the soft tissue of the breast. It is typically pouch-shaped and made of thin, flexible, plastic (e.g., polyurethane) that contains a small quantity of fluid silicone and/or air, allowing it to conform to the user's breast and reduce skin friction between the hand and the surface of the breast. The device will allow the user to sense subtle tissue density variations. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: IYO

Device Name: System, Imaging, Pulsed Echo, Ultrasonic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1560

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00083059012071

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A